COFEPRIS Releases 34 New Medications (Part II)

Continuing with last week’s summary on key medications released by COFEPRIS in Dec. 18, 2017, today’s list will be a review of drugs that target autoimmune diseases.

Autoimmune diseases

The immune system is responsible for protecting the body against foreign substances or pathogens. However, malfunctions in the immune system may cause it to erroneously attack many different healthy cells, damaging tissues and organs. While autoimmune diseases cannot be cured, some can be managed, improving life expectancy and quality for those who suffer from them.

Among the 24 medications approved by COFEPRIS are four that can be used to treat different autoimmune disease: Rigetuxer, mentioned in the previous section, and the following three.

Arabinev, treatment of multiple sclerosis

Multiple sclerosis is a chronic disease that gradually and permanently damages the central nervous system through the demyelination of neurons. Neurons throughout the body transmit information across cells and organs and are involved in most body processes including thought, movement and sensory perception. Neurons are composed of a cell body, an axon and dendrites. Myelin insulates axons, the nerve fibers, facilitating the transmission of electric signals for their communication to another neuron. If damaged, myelin loses its insulating capabilities, impairing the conduction of electric signals and even damaging the neuron. Multiple sclerosis is one of the diseases that cause the demyelination of neurons. It affects 30 out of every 100,000 people and there are 20,000 cases diagnosed in Mexico. While there is no cure for multiple sclerosis, several medications have been developed to control its symptoms and to slow the disease’s progression. Arabinev (Interferon beta-1b) binds to type I interferon receptors and reduces neuron inflammation.

Olumiant, treatment of rheumatoid arthritis

Approximately 2 million adults and 6,000 children suffered from rheumatoid arthritis in Mexico in 2017, with women representing three out of every four patients. Not to be confused with osteoarthritis or “wear and tear” arthritis, rheumatoid arthritis is a chronic autoimmune disorder that manifests most commonly in an inflammation of joints but can also damage blood vessels, eyes, heart, lungs and skin. Olumiant (Baricitinib), approved for the treatment of rheumatoid arthritis in adults, inhibits JAK enzymes, which are associated with inflammation. While the medication was approved by the FDA in February 2017, in July the agency indicated a need for more clinical trials due to serious blood clots occurring in patients, delaying the launching of the drug until mid-2018 in the US.

Otezla, treatment of psoriasis and psoriatic arthritis

Psoriasis is a chronic disease that manifests itself in the form of skin inflammation and affects over 125 million people worldwide. While the disease has a good prognosis for most patients, between 15 and 25 percent of those who present psoriasis may also develop inflation of the joints, known as psoriatic arthritis, which can also manifest in other tissues including eyes, lungs, kidneys and heart. While psoriasis and psoriatic arthritis are not curable, their symptoms can be controlled with medication such as Otezla (Apremilast), which is a selective inhibitor of phosphodiesterase 4 that reduces the cell’s inflammatory response.

Other medications approved in this package include Thymoglobulin, composed of Immunoglobulin Anti-thymocyte T Human, which is used for kidney transplant immunosuppression.